| Code | 8458C | ||||||||||
| MA number | 69/0232/18-S | ||||||||||
| Product Form: | aer ors 1x30 ml/176 vstrekov (fľ.HDPE s dáv.pumpou) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Cassella-med GmbH & Co. KG, Germany | ||||||||||
| Therapeutic Class: | 69 - OTORHINOLARYNGOLOGICA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product not subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 20.07.2018 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Orocalm 1,5 mg/ml _11/2023.pdf
|
| SPC: |
SPC_Orocalm 1,5 mg/ml_11/2023.pdf
|
| Safety feature | No |
| Data update: | 13.12.2023 |
